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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K904457
Device Name DIAL-AWAY PAIN
Applicant
R.F.P., Inc.
3177 S. Parker Rd.
Aurora,  CO  80014
Applicant Contact MARK K SHANER
Correspondent
R.F.P., Inc.
3177 S. Parker Rd.
Aurora,  CO  80014
Correspondent Contact MARK K SHANER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/01/1990
Decision Date 04/03/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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